Experience

From the manufacturer of Embosphere® Microspheres, the market leader in spherical embolics

Precise Calibration

Size distribution of Bearing nsPVA is more tightly calibrated than leading competitor1

Optimized Packaging

Vials feature easy-to-open, screw-top cap and the large vial size helps facilitate better grip and control; shelf life of 36 months

Color Coded

Color Coded by embolic size for easy identification

BEARING nsPVA Embolization Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

• Patients with known allergy to contrast medium may require pre-medication prior to embolization.

• Additional evaluations or precautions may be necessary in managing periprocedural care for patients with the following conditions:

a. Bleeding diathesis or hypercoagulative state;

b. Immunocompromised.

• Sterile and single use product. Never reuse a vial that has been opened. Do not use if the vial, screw-top cap, or peel pouch appears damaged.

• Ensure cleanliness and attention to technique during preparation of the device to avoid introducing contaminants.

• The appropriate size particles must be chosen based upon the lesion to be treated and the measurements taken from the baseline angiography.

• The use of sophisticated imaging equipment is necessary for successful embolization therapy.

• Appropriate facilities should be available to treat potential complications of the procedure.

Vascular embolization is a high-risk procedure. Complications may occur at any time during or after the procedure, and may include, but are not limited to, the following:

1. Postembolization syndrome

2. Foreign body reactions (i.e. pain, rash) necessitating medical intervention

3. Allergic reaction to contrast media

4. Infection necessitating medical intervention

5. Complications related to catheterization (e.g. hematoma at the site of entry, clot formation at the tip of the catheter and subsequent dislodgment, vasospasm and nerve and/or circulatory injuries, which may result in leg injury).

6. Undesirable reflux or passage of BEARING nsPVA Embolization Particles into arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds.

7. Ischemia at an undesirable location

8. Incomplete occlusion of vascular beds or territories may give rise to the possibility of postprocedural hemorrhage, development of alternative vascular pathways, recanalization or recurrence of symptoms.

9. Vessel or lesion rupture and hemorrhage

10. Recurrent hemorrhage

11. Ischemic stroke or myocardial infarction

12. Death

13. Complications of misembolization include blindness, hearing loss, loss of smell, paralysis, pulmonary embolism and death